FDA Pharmacy Compounding Regulatory Analysis Fellowship

Research opportunities are available either in the Office of New Drugs or Office of Compliance, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

In 2013, FDA began implementing the drug compounding provisions of the Drug Quality and Security Act. Drug compounding by pharmacists or physicians is a long standing tradition in which health care professionals use bulk chemical substances to create oral, topical or other medications that are not otherwise commercially available as drug products. These compounded drug products are intended to meet the needs of individual patients who are perceived to derive unacceptable health outcomes from FDA approved drugs. The new FDA program evaluates the safety and effectiveness of many bulk chemicals to treat various medical conditions, based on a public nomination process. This evaluation process will determine which bulk substances are appropriate for continued drug compounding.

Under the guidance of a mentor, the selected participant will research specific chemical substances and medical conditions that will be subject to FDA rulemaking. This may include providing summary data and analysis of available scientific literature published or submitted to the public docket, and other activities such as comprehensive literature search on specific chemical substances and the scientific information available regarding their use as drugs, summary and analysis of key findings, limitations and published data.

The qualified candidate should be currently pursuing a bachelor's, master's or doctoral degree in one of the relevant fields.

Preferred skills:

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0512) in your email.